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Gce Zen-O Portable Oxygen Concentrator

by Oxus, Inc. 510(k)

Active United States

510(k) K162433

Overview

The Gce Zen-O Portable Oxygen Concentrator is a portable oxygen generator. It delivers oxygen in continuous and pulse modes.

The device is supplied with AC/DC charging and has a flow rate of up to 2 LPM. It is regulated under 868.5440 and has been cleared with FDA 510K number K162433.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162433 Date24 May 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1980-2025 FDA Class II initiated 8 May 2025

    Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

Specification

510(k)

510(k) Number
FDA Product Code
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Oxus, Inc.

Questions

  • What is the GCE Zen-O Portable Oxygen Concentrator used for?

    The GCE Zen-O Portable Oxygen Concentrator is used to deliver oxygen in continuous and pulse modes, making it suitable for patients who require supplemental oxygen therapy.

  • What is the flow rate of the GCE Zen-O Portable Oxygen Concentrator?

    The GCE Zen-O Portable Oxygen Concentrator has a flow rate of up to 2 LPM.

  • Is the GCE Zen-O Portable Oxygen Concentrator regulated by the FDA?

    Yes, the GCE Zen-O Portable Oxygen Concentrator is regulated under 868.5440 and has been cleared with FDA 510K number K162433.

  • How is the GCE Zen-O Portable Oxygen Concentrator powered?

    The GCE Zen-O Portable Oxygen Concentrator is supplied with AC/DC charging, allowing for flexible power options.